Supply of Compound. 3.3.1 Upon request of ENS, ROCHE shall supply to ENS at cost 2 g of reference samples of Compound for research purposes only.
3.3.2 Upon request of ENS, ROCHE shall supply to ENS samples for clinical trials at a cost of CHF 60,000 per kg. However, the supply of Compound under this Section 3.3. shall be limited to the following Compound existing and available at ROCHE: lot # 8 11 02B 2203 01 - 13. Nov. 1998 - **** approx. 35g on stock, milled
Supply of Compound. In the event that ADVANCIS requires Compound to fulfill its internal manufacturing needs for Compound or its manufacturing needs for Compound under any agreement relating to Compound which it enters into with a Third Party, ADVANCIS shall present an offer to GSK to purchase Compound from GSK. In the event that within thirty (30) days GSK accepts the offer to supply Compound to ADVANCIS, the parties shall negotiate the terms of such supply in a definitive supply agreement (the "Supply Agreement") within sixty (60) days after the acceptance of the offer to supply, or such later date as is agreed upon in writing between the Parties. The Supply Agreement will contain terms and conditions as are customary in the pharmaceutical industry and shall include, but not be limited to terms covering the quality, specifications, yield, quantity, payment, batch failure, change control, regulatory obligations and audits, audit rights, information related to manufacture of Product, QA release, testing and shipping requirements. Notwithstanding the above, in no event shall such Supply Agreement require ADVANCIS to use GSK as its single source for its requirements of Compound for either its internal needs or for any agreement for Compound which it enters into with a Third Party, or require ADVANCIS to make such an offer only to GSK and not a Third Party.
Supply of Compound. 6.1 Subject to (i) existing quantities of bulk Compound, granulated, formulated Compound and tableted, formulated Compound in Syntex's possession and (ii) Syntex's commitment to provide certain quantities of such materials to Syntex's Third Party Licensee, Syntex shall provide to CVT (x) at no charge, any combination of free goods consisting of bulk Compound, granulated, formulated Compound and tableted, formulated Compound having a total value of [ ] as calculated based on the prices listed on Appendix C hereto, and (y) at CVT's expense, such other agreed to quantities of bulk Compound, granulated, formulated Compound and tableted, formulated Compound in Syntex's possession at the prices set forth in Appendix C. CVT shall order and complete
Supply of Compound. Except as set forth in Section 2.3, Lilly shall have no obligation to supply quantities of any Licensed Compound.
Supply of Compound. The Parties acknowledge that GelTex is in the early stages of defining contractual relationships with contract manufacturers for the manufacture and supply of Compound. The Parties agree that Sankyo and GelTex will work together in identifying and contracting with manufacturers of Drug Substance, as well as formulators to tablet, package and label the final Compound in quantities sufficient to meet the requirements of Sankyo. The parties further agree that any contractual relationships will be subject to the commitments to DSM Chemie Linz made prior to the Effective Date. In addition, GelTex agrees to provide to Sankyo written notice of the key terms of any manufacturing contract relating to the manufacture of the Compound prior to the execution of the contract, and to consider any comments Sankyo provides regarding the key contract terms. Sankyo will source all of its requirements for Drug Substance from GelTex, and the terms and conditions under which GelTex shall supply such Drug Substance shall be set forth in separate supply and quality agreements to be entered into between the Parties at such time as GelTex has further defined its relationships with contract manufacturers. Such terms and conditions shall be substantially similar to those terms and conditions under which GelTex is obligated to supply Cholestagel, as set forth in the Cholestagel Agreement.
Supply of Compound. It is anticipated that timely development of Compound and/or a Product will require the manufacture of significant amounts of the Compound, and that successful worldwide commercialization of a Product will require annual production of large quantities of the Compound.
(a) In accordance with the provisions of Section 4.04, Agouron shall purchase from JE, and JE shall timely deliver Compound for use in the development and Registration activities for Compound and/or Product, including using Compound to make Product to be used in clinical studies and trials and for special license sales. *
(b) In accordance with the provisions of Section 4.04, Agouron shall purchase from JE, and JE shall timely deliver Compound for use in making the finished dosage form(s) of Product to be sold in the Licensed Territory, *
(c) JE shall maintain books of account and complete and accurate records of all of its FBMCC of procuring and/or producing such Compound *
(iv) Sale and delivery of Compound will be subject to an agreed-upon form of purchase order being issuedby Agouron and accepted by JE. *
Supply of Compound. Xxxxx shall not be obligated to supply any quantities of the Compound to Licensee or Sublicensee(s).
Supply of Compound. Together with the Development Plan to be submitted by Elixir as per Section 6.1, Elixir shall submit to Kissei an estimate of the quantities of the Compound necessary for the development of the Product by Elixir or another Developing Party in the Territory before the first commercial sale of the first Product by Elixir or any of its Affiliates or Elixir Sublicensees, including the timing of delivery of such quantities. Kissei shall supply Elixir with all requirements for the Compound in such form acceptable to both Parties that Elixir or another Developing Party requires for conducting any development work (including for clinical trials) for obtaining the Marketing Approval of the Product in the Territory. Such supply of the Compound shall be provided at the cost of * per kilogram delivered CIF manner. Such supply of Compound shall satisfy U.S. “cGMP” (as such term is customarily understood).
Supply of Compound. Promptly after the Effective Date, UCL shall make available to Ocera at no cost all quantities of Compound, including, without limitation, any raw materials and intermediates, UCL currently has on-hand for use solely in non-clinical studies. UCL shall have no other obligations under this Agreement to supply Compound or Licensed Product to Ocera for any purposes, including, without limitation, clinical purposes and commercial purposes, unless otherwise mutually agreed in writing by the parties. Any quantities of Compound supplied by either party for use solely in non-clinical studies are supplied on an ‘as is’ basis and without any warranty or representation as to its quality or fitness for any purpose.
Supply of Compound. In order to safeguard the quality standards of the Compound and of the Products, it is understood that subject to the terms of me Supply Agreement ALFA will be the sole and exclusive supplier of the Compound to SALIX and SALIX undertakes to purchase the Compound exclusively from ALFA subject to the provisions contained in the Supply Agreement.
